# C_2012293EN.01000901.xml

| 28.9.2012 | EN | Official Journal of the European Union | C 293/9 |
| --- | --- | --- | --- |

28.9.2012

EN

Official Journal of the European Union

C 293/9

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2012 to 31 August 2012

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
   (1)
  or Article 38 of Directive 2001/82/EC
   (2)
  )

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC

1

or Article 38 of Directive 2001/82/EC

2

)

2012/C 293/02

—   Issuing, maintenance or modification of a national marketing authorization

Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 23/8/2012 | Zinnat and associated names | See Annex | See Annex | 27/8/2012 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

23/8/2012

Zinnat and associated names

See Annex

See Annex

27/8/2012

---

(1)  OJ L 311, 28.11.2001, p. 67.

1

(2)  OJ L 311, 28.11.2001, p. 1.

2

---

ANNEX

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State
  (EU/EEA) | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| A-1140 Wien |
| AUSTRIA |

Member State

(EU/EEA)

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Content

(concentration)

Austria

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien

AUSTRIA

Zinnat 125 mg/5 ml – Granulat zur Herstellung einer Suspension zum Einnehmen

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Austria

| GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| --- |
| A-1140 Wien |
| AUSTRIA |

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien

AUSTRIA

Zinnat 250 mg – Granulat

250 mg

Granules

Oral use

N/A

Austria

| GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| --- |
| A-1140 Wien |
| AUSTRIA |

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien

AUSTRIA

Zinnat 250 mg/5 ml – Granulat zur Herstellung einer Suspension zum Einnehmen

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Austria

| GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| --- |
| A-1140 Wien |
| AUSTRIA |

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien

AUSTRIA

Zinnat 250 mg – Filmtabletten

250 mg

Film-coated Tablets

Oral use

N/A

Austria

| GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| --- |
| A-1140 Wien |
| AUSTRIA |

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien

AUSTRIA

Zinnat 500 mg – Filmtabletten

500 mg

Film-coated Tablets

Oral use

N/A

Belgium

| GlaxoSmithKline s.a./n.v. Rue du Tilleul 13 |
| --- |
| 1332 Genval |
| BELGIUM |

GlaxoSmithKline s.a./n.v. Rue du Tilleul 13

1332 Genval

BELGIUM

Zinnat

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Belgium

| GlaxoSmithKline s.a./n.v. Rue du Tilleul 13 |
| --- |
| 1332 Genval |
| BELGIUM |

GlaxoSmithKline s.a./n.v. Rue du Tilleul 13

1332 Genval

BELGIUM

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Belgium

| GlaxoSmithKline s.a./n.v. Rue du Tilleul 13 |
| --- |
| 1332 Genval |
| BELGIUM |

GlaxoSmithKline s.a./n.v. Rue du Tilleul 13

1332 Genval

BELGIUM

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Bulgaria

GlaxoSmithKline EOOD, Ivan Vazov complex, Dimitar Manov Str., bld 10, 1408 Sofia, BULGARIA

Zinnat

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Bulgaria

| Glaxo Group Ltd., Greenford road, Greenford, Middlesex, UB6 0NN, |
| --- |
| UNITED KINGDOM |

Glaxo Group Ltd., Greenford road, Greenford, Middlesex, UB6 0NN,

UNITED KINGDOM

Zinnat

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Bulgaria

GlaxoSmithKline EOOD, Ivan Vazov complex, Dimitar Manov Str., bld 10, 1408 Sofia, BULGARIA

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Bulgaria

GlaxoSmithKline EOOD, Ivan Vazov complex, Dimitar Manov Str., bld 10, 1408 Sofia, BULGARIA

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Cyprus

| Glaxo Group Limited |
| --- |
| Berkeley Avenue |
| Greenford |
| Middlesex UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlesex UB6 0NN

UNITED KINGDOM

Zinnat

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Cyprus

| Glaxo Group Limited |
| --- |
| Berkeley Avenue |
| Greenford |
| Middlesex UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlesex UB6 0NN

UNITED KINGDOM

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Cyprus

| Glaxo Group Limited |
| --- |
| Berkeley Avenue |
| Greenford |
| Middlesex UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlesex UB6 0NN

UNITED KINGDOM

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Czech Republic

| Glaxo Group Ltd., |
| --- |
| Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN |
| ENGLAND |

Glaxo Group Ltd.,

Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN

ENGLAND

Zinnat 125 mg

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Czech Republic

| Glaxo Group Ltd., |
| --- |
| Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN |
| ENGLAND |

Glaxo Group Ltd.,

Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN

ENGLAND

Zinnat 250 mg

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Czech Republic

| Glaxo Group Ltd., |
| --- |
| Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN |
| ENGLAND |

Glaxo Group Ltd.,

Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN

ENGLAND

Zinnat 125 mg

125 mg

Film-coated Tablets

Oral use

N/A

Czech Republic

| Glaxo Group Ltd., |
| --- |
| Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN |
| ENGLAND |

Glaxo Group Ltd.,

Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN

ENGLAND

Zinnat 250 mg

250 mg

Film-coated Tablets

Oral use

N/A

Czech Republic

| Glaxo Group Ltd., |
| --- |
| Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN |
| ENGLAND |

Glaxo Group Ltd.,

Glaxo Welcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN

ENGLAND

Zinnat 500 mg

500 mg

Film-coated Tablets

Oral use

N/A

Denmark

| GlaxoSmithKline Pharma A/S |
| --- |
| Nykaer 68, 2605 Broendby |
| DENMARK |

GlaxoSmithKline Pharma A/S

Nykaer 68, 2605 Broendby

DENMARK

Zinnat

125 mg/5 ml (25 mg/ml)

Granules for Oral Suspension

Oral use

125 mg/5 ml

Denmark

| GlaxoSmithKline Pharma A/S |
| --- |
| Nykaer 68, 2605 Broendby |
| DENMARK |

GlaxoSmithKline Pharma A/S

Nykaer 68, 2605 Broendby

DENMARK

Zinnat

125 mg

Film-coated Tablets

Oral use

N/A

Denmark

| GlaxoSmithKline Pharma A/S |
| --- |
| Nykaer 68, 2605 Broendby |
| DENMARK |

GlaxoSmithKline Pharma A/S

Nykaer 68, 2605 Broendby

DENMARK

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Denmark

| GlaxoSmithKline Pharma A/S |
| --- |
| Nykaer 68, 2605 Broendby |
| DENMARK |

GlaxoSmithKline Pharma A/S

Nykaer 68, 2605 Broendby

DENMARK

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Estonia

| Glaxo Group Ltd. |
| --- |
| Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Ltd.

Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN

UNITED KINGDOM

Zinnat

25 mg/1 ml

Granules for Oral Suspension

Oral use

25 mg/1 ml

Estonia

| Glaxo Group Ltd. |
| --- |
| Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Ltd.

Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN

UNITED KINGDOM

Zinnat

250 mg

Film-coated Tablet

Oral use

N/A

Estonia

| Glaxo Group Ltd. |
| --- |
| Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Ltd.

Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN

UNITED KINGDOM

Zinnat

500 mg

Film-coated Tablet

Oral use

N/A

Finland

| GlaxoSmithKline Oy |
| --- |
| P.O.Box 24 (Piispansilta 9 A), FI-02231 Espoo, FINLAND |

GlaxoSmithKline Oy

P.O.Box 24 (Piispansilta 9 A), FI-02231 Espoo, FINLAND

Zinnat

50 mg/ml

Granules for Oral Suspension

Oral use

N/A

Finland

Glaxo Operations UK Ltd, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, UNITED KINGDOM

Zinnat

125 mg

Film-coated Tablets

Oral use

N/A

Finland

Glaxo Operations UK Ltd, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, UNITED KINGDOM

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

France

| Laboratoire GlaxoSmithKline |
| --- |
| 100, route de Versailles – 78163 Marly-le-Roi Cedex |
| FRANCE |

Laboratoire GlaxoSmithKline

100, route de Versailles – 78163 Marly-le-Roi Cedex

FRANCE

Zinnat 125 mg/5 ml Enfants et Nourrissons

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

France

| Laboratoire GlaxoSmithKline |
| --- |
| 100, route de Versailles – 78163 Marly-le-Roi Cedex |
| FRANCE |

Laboratoire GlaxoSmithKline

100, route de Versailles – 78163 Marly-le-Roi Cedex

FRANCE

Zinnat

125 mg

Film-coated Tablets

Oral use

N/A

France

| Laboratoire GlaxoSmithKline |
| --- |
| 100, route de Versailles – 78163 Marly-le-Roi Cedex |
| FRANCE |

Laboratoire GlaxoSmithKline

100, route de Versailles – 78163 Marly-le-Roi Cedex

FRANCE

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

France

| Laboratoire GlaxoSmithKline |
| --- |
| 100, route de Versailles – 78163 Marly-le-Roi Cedex |
| FRANCE |

Laboratoire GlaxoSmithKline

100, route de Versailles – 78163 Marly-le-Roi Cedex

FRANCE

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

France

| Laboratoire GlaxoSmithKline |
| --- |
| 100, route de Versailles – 78163 Marly-le-Roi Cedex |
| FRANCE |

Laboratoire GlaxoSmithKline

100, route de Versailles – 78163 Marly-le-Roi Cedex

FRANCE

Zinnat 125 mg Enfants et Nourrissons

125 mg

Granules for Oral Suspension in sachet

Oral use

N/A

Germany

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 |
| --- |
| 80339 München |
| GERMANY |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

GERMANY

Zinnat -Trockensaft

125 mg/5 ml (25 mg/ml)

Granules for Oral Suspension

Oral use

125 mg/5 ml

Germany

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 |
| --- |
| 80339 München |
| GERMANY |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

GERMANY

Zinnat

125 mg

Film-coated Tablets

Oral use

N/A

Germany

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 |
| --- |
| 80339 München |
| GERMANY |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

GERMANY

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Germany

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 |
| --- |
| 80339 München |
| GERMANY |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

GERMANY

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Germany

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 |
| --- |
| 80339 München |
| GERMANY |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

GERMANY

Elobact 125 mg Dosier-Brief

125 mg

Granules for Oral Suspension

Oral use

N/A

Germany

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 |
| --- |
| 80339 München |
| GERMANY |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

GERMANY

Elobact Trockensaft

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Germany

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 |
| --- |
| 80339 München |
| GERMANY |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

GERMANY

Elobact 250 mg Dosier-Brief

250 mg

Granules for Oral Suspension

Oral use

N/A

Germany

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 |
| --- |
| 80339 München |
| GERMANY |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

GERMANY

Elobact

125 mg

Film-coated Tablets

Oral use

N/A

Germany

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 |
| --- |
| 80339 München |
| GERMANY |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

GERMANY

Elobact

250 mg

Film-coated Tablets

Oral use

N/A

Germany

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11 |
| --- |
| 80339 München |
| GERMANY |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11

80339 München

GERMANY

Elobact

500 mg

Film-coated Tablets

Oral use

N/A

Greece

| GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, |
| --- |
| 152 32 Halandri, Athens |
| GREECE |

GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,

152 32 Halandri, Athens

GREECE

Zinadol

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Greece

| GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, |
| --- |
| 152 32 Halandri, Athens |
| GREECE |

GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,

152 32 Halandri, Athens

GREECE

Zinadol

250 mg

Film-coated Tablets

Oral use

N/A

Greece

| GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, |
| --- |
| 152 32 Halandri, Athens |
| GREECE |

GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,

152 32 Halandri, Athens

GREECE

Zinadol

500 mg

Film-coated Tablets

Oral use

N/A

Hungary

| GlaxoSmithKline Kft. |
| --- |
| 1124 Bp, Csörsz u. 43. |
| HUNGARY |

GlaxoSmithKline Kft.

1124 Bp, Csörsz u. 43.

HUNGARY

Zinnat

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Hungary

| GlaxoSmithKline Kft. |
| --- |
| 1124 Bp, Csörsz u. 43. |
| HUNGARY |

GlaxoSmithKline Kft.

1124 Bp, Csörsz u. 43.

HUNGARY

Zinnat

125 mg

Film-coated Tablets

Oral use

N/A

Hungary

| GlaxoSmithKline Kft. |
| --- |
| 1124 Bp, Csörsz u. 43. |
| HUNGARY |

GlaxoSmithKline Kft.

1124 Bp, Csörsz u. 43.

HUNGARY

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Hungary

| GlaxoSmithKline Kft. |
| --- |
| 1124 Bp, Csörsz u. 43. |
| HUNGARY |

GlaxoSmithKline Kft.

1124 Bp, Csörsz u. 43.

HUNGARY

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Iceland

| GlaxoSmithKline ehf. |
| --- |
| Thverholt 14 |
| 105 Reykjavík. |
| ICELAND |

GlaxoSmithKline ehf.

Thverholt 14

105 Reykjavík.

ICELAND

Zinnat

250 mg/5 ml

(25 mg/ml)

Granules for Oral Suspension

Oral use

250 mg/5 ml

Iceland

| GlaxoSmithKline ehf. |
| --- |
| Thverholt 14 |
| 105 Reykjavík. |
| ICELAND |

GlaxoSmithKline ehf.

Thverholt 14

105 Reykjavík.

ICELAND

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Ireland

| GlaxoSmithKline (Ireland) Limited |
| --- |
| Stonemasons Way, |
| Rathfarnham, |
| Dublin 16 |
| IRELAND |

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham,

Dublin 16

IRELAND

Zinnat

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Ireland

| GlaxoSmithKline (Ireland) Limited |
| --- |
| Stonemasons Way, |
| Rathfarnham, |
| Dublin 16 |
| IRELAND |

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham,

Dublin 16

IRELAND

Zinnat

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Ireland

| GlaxoSmithKline (Ireland) Limited |
| --- |
| Stonemasons Way, |
| Rathfarnham, |
| Dublin 16 |
| IRELAND |

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham,

Dublin 16

IRELAND

Zinnat

125 mg

Film-coated Tablets

Oral use

N/A

Ireland

| GlaxoSmithKline (Ireland) Limited |
| --- |
| Stonemasons Way, |
| Rathfarnham, |
| Dublin 16 |
| IRELAND |

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham,

Dublin 16

IRELAND

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| ITALY |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

ITALY

Zinnat

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| ITALY |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

ITALY

Zinnat

250 mg

Granules for Oral Suspension

Oral use

N/A

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| ITALY |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

ITALY

Zinnat

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| ITALY |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

ITALY

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| ITALY |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

ITALY

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| ITALY |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

ITALY

Zoref

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| ITALY |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

ITALY

Zoref

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| ITALY |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

ITALY

Zoref

250 mg

Film-coated Tablets

Oral use

N/A

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| ITALY |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

ITALY

Zoref

500 mg

Film-coated Tablets

Oral use

N/A

Italy

| Malesci Istituto Farmacobiologico S.p.A |
| --- |
| Via Lungo l’Ema 7, |
| 50012 Bagno A Ripoli |
| Firenze |
| ITALY |

Malesci Istituto Farmacobiologico S.p.A

Via Lungo l’Ema 7,

50012 Bagno A Ripoli

Firenze

ITALY

Oraxim

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Italy

| Malesci Istituto Farmacobiologico S.p.A |
| --- |
| Via Lungo l’Ema 7, |
| 50012 Bagno A Ripoli |
| Firenze |
| ITALY |

Malesci Istituto Farmacobiologico S.p.A

Via Lungo l’Ema 7,

50012 Bagno A Ripoli

Firenze

ITALY

Oraxim

250 mg

Granules for Oral Suspension

Oral use

N/A

Italy

| Malesci Istituto Farmacobiologico S.p.A |
| --- |
| Via Lungo l’Ema 7, |
| 50012 Bagno A Ripoli |
| Firenze |
| ITALY |

Malesci Istituto Farmacobiologico S.p.A

Via Lungo l’Ema 7,

50012 Bagno A Ripoli

Firenze

ITALY

Oraxim

125 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Italy

| Malesci Istituto Farmacobiologico S.p.A |
| --- |
| Via Lungo l’Ema 7, |
| 50012 Bagno A Ripoli |
| Firenze |
| ITALY |

Malesci Istituto Farmacobiologico S.p.A

Via Lungo l’Ema 7,

50012 Bagno A Ripoli

Firenze

ITALY

Oraxim

250 mg

Film-coated Tablets

Oral use

N/A

Italy

| Malesci Istituto Farmacobiologico S.p.A |
| --- |
| Via Lungo l’Ema 7, |
| 50012 Bagno A Ripoli |
| Firenze |
| ITALY |

Malesci Istituto Farmacobiologico S.p.A

Via Lungo l’Ema 7,

50012 Bagno A Ripoli

Firenze

ITALY

Oraxim

500 mg

Film-coated Tablets

Oral use

N/A

Latvia

| GlaxoSmithKline Latvia SIA, Bruņinieku 5, Rīga, LV-1001 |
| --- |
| LATVIA |

GlaxoSmithKline Latvia SIA, Bruņinieku 5, Rīga, LV-1001

LATVIA

Zinnat 25 mg/ml granulas iekšķīgi lietojamas suspensijas pagatavošanai

125 mg/5 ml

(25 mg/ml)

Granules for Oral Suspension

Oral use

125 mg/5 ml

Latvia

| GlaxoSmithKline Latvia SIA, Bruņinieku 5, Rīga, LV-1001 |
| --- |
| LATVIA |

GlaxoSmithKline Latvia SIA, Bruņinieku 5, Rīga, LV-1001

LATVIA

Zinnat 250 mg apvalkotās tabletes

250 mg

Film-coated Tablets

Oral use

N/A

Latvia

| GlaxoSmithKline Latvia SIA, Bruņinieku 5, Rīga, LV-1001 |
| --- |
| LATVIA |

GlaxoSmithKline Latvia SIA, Bruņinieku 5, Rīga, LV-1001

LATVIA

Zinnat 500 mg apvalkotās tabletes

500 mg

Film-coated Tablets

Oral use

N/A

Lithuania

| UAB ‘GlaxoSmithKline Lietuva’, |
| --- |
| A. Goštauto g. 40A, |
| LT-01112 Vilnius, LITHUANIA |

UAB ‘GlaxoSmithKline Lietuva’,

A. Goštauto g. 40A,

LT-01112 Vilnius, LITHUANIA

Zinnat

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Lithuania

| UAB ‘GlaxoSmithKline Lietuva’, |
| --- |
| A. Goštauto g. 40A, |
| LT-01112 Vilnius, LITHUANIA |

UAB ‘GlaxoSmithKline Lietuva’,

A. Goštauto g. 40A,

LT-01112 Vilnius, LITHUANIA

Zinnat

125 mg

Film-coated Tablets

Oral use

N/A

Lithuania

| UAB ‘GlaxoSmithKline Lietuva’, |
| --- |
| A. Goštauto g. 40A, |
| LT-01112 Vilnius, LITHUANIA |

UAB ‘GlaxoSmithKline Lietuva’,

A. Goštauto g. 40A,

LT-01112 Vilnius, LITHUANIA

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Lithuania

| UAB ‘GlaxoSmithKline Lietuva’, |
| --- |
| A. Goštauto g. 40A, |
| LT-01112 Vilnius, LITHUANIA |

UAB ‘GlaxoSmithKline Lietuva’,

A. Goštauto g. 40A,

LT-01112 Vilnius, LITHUANIA

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Luxembourg

| GLAXOSMITHKLINE PHARMACEUTICALS SA |
| --- |
| 2-4-6, AVENUE PASCAL B-1330 WAVRE |

GLAXOSMITHKLINE PHARMACEUTICALS SA

2-4-6, AVENUE PASCAL B-1330 WAVRE

Zinnat

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Luxembourg

| GLAXOSMITHKLINE PHARMACEUTICALS SA |
| --- |
| 2-4-6, AVENUE PASCAL B-1330 WAVRE |

GLAXOSMITHKLINE PHARMACEUTICALS SA

2-4-6, AVENUE PASCAL B-1330 WAVRE

Zinnat

250 mg

Granules for Oral Suspension

Oral use

N/A

Luxembourg

| GLAXOSMITHKLINE PHARMACEUTICALS SA |
| --- |
| 2-4-6, AVENUE PASCAL B-1330 WAVRE |

GLAXOSMITHKLINE PHARMACEUTICALS SA

2-4-6, AVENUE PASCAL B-1330 WAVRE

Zinnat

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Luxembourg

| GLAXOSMITHKLINE PHARMACEUTICALS SA |
| --- |
| 2-4-6, AVENUE PASCAL B-1330 WAVRE |

GLAXOSMITHKLINE PHARMACEUTICALS SA

2-4-6, AVENUE PASCAL B-1330 WAVRE

Zinnat

125 mg

Film-coated Tablets

Oral use

N/A

Luxembourg

| GLAXOSMITHKLINE PHARMACEUTICALS SA |
| --- |
| 2-4-6, AVENUE PASCAL B-1330 WAVRE |

GLAXOSMITHKLINE PHARMACEUTICALS SA

2-4-6, AVENUE PASCAL B-1330 WAVRE

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Luxembourg

| GLAXOSMITHKLINE PHARMACEUTICALS SA |
| --- |
| 2-4-6, AVENUE PASCAL B-1330 WAVRE |

GLAXOSMITHKLINE PHARMACEUTICALS SA

2-4-6, AVENUE PASCAL B-1330 WAVRE

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Malta

GlaxoSmithKline (Ireland) Ltd. Stonemasons Way, Rathfarnham, Dublin 16 IRELAND

Zinnat

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Malta

GlaxoSmithKline (Ireland) Ltd. Stonemasons Way, Rathfarnham, Dublin 16 IRELAND

Zinnat

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Malta

| Glaxo Wellcome UK Limited |
| --- |
| Glaxo Wellcome House |
| Berkeley avenue |
| Greenford, Middlesex |
| United Kingdom |
| UB6 0NN |

Glaxo Wellcome UK Limited

Glaxo Wellcome House

Berkeley avenue

Greenford, Middlesex

United Kingdom

UB6 0NN

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Malta

GlaxoSmithKline (Ireland) Ltd. Stonemasons Way, Rathfarnham, Dublin 16 IRELAND

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Netherlands

| Glaxo Smith Kline B.V. |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ ZEIST |
| NETHERLANDS |

Glaxo Smith Kline B.V.

Huis ter Heideweg 62

3705 LZ ZEIST

NETHERLANDS

Zinnat

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Netherlands

| Glaxo Smith Kline B.V. |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ ZEIST |
| NETHERLANDS |

Glaxo Smith Kline B.V.

Huis ter Heideweg 62

3705 LZ ZEIST

NETHERLANDS

Zinnat

125 mg

Film-coated Tablets

Oral use

N/A

Netherlands

| Glaxo Smith Kline B.V. |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ ZEIST |
| NETHERLANDS |

Glaxo Smith Kline B.V.

Huis ter Heideweg 62

3705 LZ ZEIST

NETHERLANDS

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Netherlands

| Glaxo Smith Kline B.V. |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ ZEIST |
| NETHERLANDS |

Glaxo Smith Kline B.V.

Huis ter Heideweg 62

3705 LZ ZEIST

NETHERLANDS

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Poland

| GlaxoSmithKline Export Ltd |
| --- |
| 980 Great West Road |
| Brentford, Middlesex, TW8 9GS |
| UNITED KINGDOM |

GlaxoSmithKline Export Ltd

980 Great West Road

Brentford, Middlesex, TW8 9GS

UNITED KINGDOM

Zinnat

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Poland

| GlaxoSmithKline Export Ltd |
| --- |
| 980 Great West Road |
| Brentford, Middlesex, TW8 9GS |
| UNITED KINGDOM |

GlaxoSmithKline Export Ltd

980 Great West Road

Brentford, Middlesex, TW8 9GS

UNITED KINGDOM

Zinnat

250 mg

Granules for Oral Suspension

Oral use

N/A

Poland

| GlaxoSmithKline Export Ltd |
| --- |
| 980 Great West Road |
| Brentford, Middlesex, TW8 9GS |
| UNITED KINGDOM |

GlaxoSmithKline Export Ltd

980 Great West Road

Brentford, Middlesex, TW8 9GS

UNITED KINGDOM

Zinnat

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Poland

| GlaxoSmithKline Export Ltd |
| --- |
| 980 Great West Road |
| Brentford, Middlesex, TW8 9GS |
| UNITED KINGDOM |

GlaxoSmithKline Export Ltd

980 Great West Road

Brentford, Middlesex, TW8 9GS

UNITED KINGDOM

Zinnat

125 mg

Film-coated Tablets

Oral use

N/A

Poland

| GlaxoSmithKline Export Ltd |
| --- |
| 980 Great West Road |
| Brentford, Middlesex, TW8 9GS |
| UNITED KINGDOM |

GlaxoSmithKline Export Ltd

980 Great West Road

Brentford, Middlesex, TW8 9GS

UNITED KINGDOM

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Poland

| GlaxoSmithKline Export Ltd |
| --- |
| 980 Great West Road |
| Brentford, Middlesex, TW8 9GS |
| UNITED KINGDOM |

GlaxoSmithKline Export Ltd

980 Great West Road

Brentford, Middlesex, TW8 9GS

UNITED KINGDOM

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Portugal

| Instituto Luso-Fármaco, Lda. |
| --- |
| Rua Dr António Loureiro Borges no3 |
| Arquiparque – Miraflores |
| 1495-131 Algés |
| PORTUGAL |

Instituto Luso-Fármaco, Lda.

Rua Dr António Loureiro Borges no3

Arquiparque – Miraflores

1495-131 Algés

PORTUGAL

Zipos

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Portugal

| Instituto Luso-Fármaco, Lda. |
| --- |
| Rua Dr António Loureiro Borges no3 |
| Arquiparque – Miraflores |
| 1495-131 Algés |
| PORTUGAL |

Instituto Luso-Fármaco, Lda.

Rua Dr António Loureiro Borges no3

Arquiparque – Miraflores

1495-131 Algés

PORTUGAL

Zipos

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Portugal

| Instituto Luso-Fármaco, Lda. |
| --- |
| Rua Dr António Loureiro Borges no3 |
| Arquiparque – Miraflores |
| 1495-131 Algés |
| PORTUGAL |

Instituto Luso-Fármaco, Lda.

Rua Dr António Loureiro Borges no3

Arquiparque – Miraflores

1495-131 Algés

PORTUGAL

Zipos

250 mg

Film-coated Tablets

Oral use

N/A

Portugal

| Instituto Luso-Fármaco, Lda. |
| --- |
| Rua Dr António Loureiro Borges no3 |
| Arquiparque – Miraflores |
| 1495-131 Algés |
| PORTUGAL |

Instituto Luso-Fármaco, Lda.

Rua Dr António Loureiro Borges no3

Arquiparque – Miraflores

1495-131 Algés

PORTUGAL

Zipos

500 mg

Film-coated Tablets

Oral use

N/A

Portugal

| GlaxoWellcome Farmacêutica Lda |
| --- |
| Rua Dr António Loureiro Borges no3 |
| Arquiparque – Miraflores |
| 1495-131 Algés |
| PORTUGAL |

GlaxoWellcome Farmacêutica Lda

Rua Dr António Loureiro Borges no3

Arquiparque – Miraflores

1495-131 Algés

PORTUGAL

Zoref

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Portugal

| GlaxoWellcome Farmacêutica Lda |
| --- |
| Rua Dr António Loureiro Borges no3 |
| Arquiparque – Miraflores |
| 1495-131 Algés |
| PORTUGAL |

GlaxoWellcome Farmacêutica Lda

Rua Dr António Loureiro Borges no3

Arquiparque – Miraflores

1495-131 Algés

PORTUGAL

Zoref

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Portugal

| GlaxoWellcome Farmacêutica Lda |
| --- |
| Rua Dr António Loureiro Borges no3 |
| Arquiparque – Miraflores |
| 1495-131 Algés |
| PORTUGAL |

GlaxoWellcome Farmacêutica Lda

Rua Dr António Loureiro Borges no3

Arquiparque – Miraflores

1495-131 Algés

PORTUGAL

Zoref

250 mg

Film-coated Tablets

Oral use

N/A

Portugal

| GlaxoWellcome Farmacêutica Lda |
| --- |
| Rua Dr António Loureiro Borges no3 |
| Arquiparque – Miraflores |
| 1495-131 Algés |
| PORTUGAL |

GlaxoWellcome Farmacêutica Lda

Rua Dr António Loureiro Borges no3

Arquiparque – Miraflores

1495-131 Algés

PORTUGAL

Zoref

500 mg

Film-coated Tablets

Oral use

N/A

Romania

| Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, |
| --- |
| UNITED KINGDOM |

Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN,

UNITED KINGDOM

Zinnat

125 mg/5 ml

Granules for Suspension

Oral use

125 mg/5 ml

Romania

| Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, |
| --- |
| UNITED KINGDOM |

Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN,

UNITED KINGDOM

Zinnat

125 mg

Film-coated Tablets

Oral use

N/A

Romania

| Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, |
| --- |
| UNITED KINGDOM |

Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN,

UNITED KINGDOM

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

Romania

| Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, |
| --- |
| UNITED KINGDOM |

Glaxo Wellcome UK Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN,

UNITED KINGDOM

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

Slovakia

| GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava |
| --- |
| Slovak Republic |

GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava

Slovak Republic

Zinnat 125 mg/5 ml

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Slovakia

| GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava |
| --- |
| Slovak Republic |

GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava

Slovak Republic

Zinnat 250 mg/5 ml

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Slovakia

| GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava |
| --- |
| Slovak Republic |

GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava

Slovak Republic

Zinnat 125 mg

125 mg

Film-coated Tablet

Oral use

N/A

Slovakia

| GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava |
| --- |
| Slovak Republic |

GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava

Slovak Republic

Zinnat 250 mg

250 mg

Film-coated Tablets

Oral use

N/A

Slovakia

| GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava |
| --- |
| Slovak Republic |

GlaxoSmithKline Slovakia s.r.o., Galvaniho7/A, 82104 Bratislava

Slovak Republic

Zinnat 500 mg

500 mg

Film-coated Tablets

Oral use

N/A

Slovenia

| GSK d.o.o., Ljubljana |
| --- |
| Cvetkova ulica 29 |
| SI-1000 Ljubljana |
| SLOVENIA |

GSK d.o.o., Ljubljana

Cvetkova ulica 29

SI-1000 Ljubljana

SLOVENIA

Zinnat 125 mg/5 ml zrnca za peroralno suspenzijo

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Slovenia

| GSK d.o.o., Ljubljana |
| --- |
| Cvetkova ulica 29 |
| SI-1000 Ljubljana |
| SLOVENIA |

GSK d.o.o., Ljubljana

Cvetkova ulica 29

SI-1000 Ljubljana

SLOVENIA

Zinnat 250 mg/5 ml zrnca za peroralno suspenzijo

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Slovenia

| GSK d.o.o., Ljubljana |
| --- |
| Cvetkova ulica 29 |
| SI-1000 Ljubljana |
| SLOVENIA |

GSK d.o.o., Ljubljana

Cvetkova ulica 29

SI-1000 Ljubljana

SLOVENIA

Zinnat 250 mg filmsko obložene tablete

250 mg

Film-coated Tablets

Oral use

N/A

Slovenia

| GSK d.o.o., Ljubljana |
| --- |
| Cvetkova ulica 29 |
| SI-1000 Ljubljana |
| SLOVENIA |

GSK d.o.o., Ljubljana

Cvetkova ulica 29

SI-1000 Ljubljana

SLOVENIA

Zinnat 500 mg filmsko obložene tablete

500 mg

Film-coated Tablets

Oral use

N/A

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid |
| C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid

C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

ZINNAT 125 mg granulado para suspensión oral en sobres

125 mg

Granules for Oral Suspension

Oral use

N/A

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

ZINNAT 125 mg/5 ml granulado para suspensión oral en frasco

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

ZINNAT 250 mg granulado para suspensión oral en sobres

250 mg

Granules for Oral Suspension

Oral use

N/A

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

ZINNAT 250 mg/5 ml granulado para suspensión oral en frasco

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid |
| C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid

C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

ZINNAT 500 mg granulado para suspensión oral en sobres

500 mg

Granules for Oral Suspension

Oral use

N/A

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

ZINNAT 125 mg comprimidos recubiertos con película

125 mg

Film-coated Tablets

Oral use

N/A

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

ZINNAT 250 mg comprimidos recubiertos con película

250 mg

Film-coated Tablets

Oral use

N/A

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

ZINNAT 500 mg comprimidos recubiertos con película

500 mg

Film-coated Tablets

Oral use

N/A

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

SELAN 125 mg sobres

125 mg

Granules for Oral Suspension

Oral use

N/A

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

SELAN 125 mg suspensión extemporánea

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

SELAN 250 mg suspensión extemporánea

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

SELAN 500 mg sobres

500 mg

Granules for Oral Suspension

Oral use

N/A

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

SELAN 125 mg comprimidos

125 mg

Film-coated Tablets

Oral use

N/A

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

SELAN 250 mg comprimidos

250 mg

Film-coated Tablets

Oral use

N/A

Spain

| GlaxoSmithKline, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

GlaxoSmithKline, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

SELAN 500 mg comprimidos

500 mg

Film-coated Tablets

Oral use

N/A

Spain

| Wellcome Farmacéutica, S.A. |
| --- |
| Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| SPAIN |

Wellcome Farmacéutica, S.A.

Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

NIVADOR 125 mg/5 ml granulado para suspensión oral en frasco

125 mg

Granules for Oral Suspension

Oral use

N/A

Spain

| Wellcome Farmacéutica, S.A. .- Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| --- |
| SPAIN |

Wellcome Farmacéutica, S.A. .- Parque Tecnológico de Madrid C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

NIVADOR 125 mg/5 ml granulado para suspensión oral en frasco

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

Spain

| Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| --- |
| SPAIN |

Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

NIVADOR 250 mg granulado para suspensión oral en sobres

250 mg

Granules for Oral Suspension

Oral use

N/A

Spain

| Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| --- |
| SPAIN |

Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

NIVADOR 250 mg/5 ml granulado para suspensión oral en frasco

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

Spain

| Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| --- |
| SPAIN |

Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

NIVADOR 500 mg granulado para suspensión oral en sobres

500 mg

Granules for Oral Suspension

Oral use

N/A

Spain

| Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| --- |
| SPAIN |

Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

NIVADOR 250 mg comprimidos recubiertos con película

250 mg

Film-coated Tablets

Oral use

N/A

Spain

| Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid) |
| --- |
| SPAIN |

Wellcome Farmacéutica, S.A. P.T.M.- C/Severo Ochoa, 2 28760 Tres Cantos (Madrid)

SPAIN

NIVADOR 500 mg comprimidos recubiertos con película

500 mg

Film-coated Tablets

Oral use

N/A

Spain

| Allen Farmacéutica, S.A. |
| --- |
| Parque Tecnológico de Madrid |
| C/Severo Ochoa, 2 |
| 28760 Tres Cantos |
| (Madrid) |
| SPAIN |

Allen Farmacéutica, S.A.

Parque Tecnológico de Madrid

C/Severo Ochoa, 2

28760 Tres Cantos

(Madrid)

SPAIN

Cefuroxima Allen 250 mg comprimidos recubiertos con película EFG

250 mg

Film-coated Tablets

Oral use

N/A

Spain

| Allen Farmacéutica, S.A. |
| --- |
| Parque Tecnológico de Madrid |
| C/Severo Ochoa, 2 |
| 28760 Tres Cantos |
| (Madrid) |
| SPAIN |

Allen Farmacéutica, S.A.

Parque Tecnológico de Madrid

C/Severo Ochoa, 2

28760 Tres Cantos

(Madrid)

SPAIN

Cefuroxima Allen 500 mg comprimidos recubiertos con película EFG

500 mg

Film-coated Tablets

Oral use

N/A

Spain

| Allen Farmacéutica, S.A. |
| --- |
| Parque Tecnológico de Madrid |
| C/Severo Ochoa, 2 |
| 28760 Tres Cantos |
| (Madrid) |
| SPAIN |

Allen Farmacéutica, S.A.

Parque Tecnológico de Madrid

C/Severo Ochoa, 2

28760 Tres Cantos

(Madrid)

SPAIN

Cefuroxima Solasma 250 mg comprimidos recubiertos con película EFG

250 mg

Film-coated Tablets

Oral use

N/A

Spain

| Allen Farmacéutica, S.A. |
| --- |
| Parque Tecnológico de Madrid |
| C/Severo Ochoa, 2 |
| 28760 Tres Cantos |
| (Madrid) |
| SPAIN |

Allen Farmacéutica, S.A.

Parque Tecnológico de Madrid

C/Severo Ochoa, 2

28760 Tres Cantos

(Madrid)

SPAIN

Cefuroxima Solasma 500 mg comprimidos recubiertos con película EFG

500 mg

Film-coated Tablets

Oral use

N/A

Sweden

| GlaxoSmithKline AB |
| --- |
| Box 516 |
| 169 29 Solna |
| SWEDEN |

GlaxoSmithKline AB

Box 516

169 29 Solna

SWEDEN

Zinnat

25 mg/ml

Granules for Oral Suspension

Oral use

N/A

Sweden

| GlaxoSmithKline AB |
| --- |
| Box 516 |
| 169 29 Solna |
| SWEDEN |

GlaxoSmithKline AB

Box 516

169 29 Solna

SWEDEN

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

United Kingdom

| Glaxo Wellcome UK Ltd, |
| --- |
| Stockley Park West, Uxbridge, Middlesex, UB11 1BT |

Glaxo Wellcome UK Ltd,

Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Zinnat

125 mg/5 ml

Granules for Oral Suspension

Oral use

125 mg/5 ml

United Kingdom

| Glaxo Wellcome UK Ltd, |
| --- |
| Stockley Park West, Uxbridge, Middlesex, UB11 1BT |

Glaxo Wellcome UK Ltd,

Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Zinnat

250 mg/5 ml

Granules for Oral Suspension

Oral use

250 mg/5 ml

United Kingdom

| Glaxo Wellcome UK Ltd, |
| --- |
| Stockley Park West, Uxbridge, Middlesex, UB11 1BT |

Glaxo Wellcome UK Ltd,

Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Zinnat

125 mg

Film-coated Tablets

Oral use

N/A

United Kingdom

| Glaxo Wellcome UK Ltd, |
| --- |
| Stockley Park West, Uxbridge, Middlesex, UB11 1BT |

Glaxo Wellcome UK Ltd,

Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Zinnat

250 mg

Film-coated Tablets

Oral use

N/A

United Kingdom

| Glaxo Wellcome UK Ltd, |
| --- |
| Stockley Park West, Uxbridge, Middlesex, UB11 1BT |

Glaxo Wellcome UK Ltd,

Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Zinnat

500 mg

Film-coated Tablets

Oral use

N/A

---